rechan.in Compliance Guidance January 2018 | Version 1.0 Health Supplements and Nutraceuticals
rechan.in
Compliance GuidanceJanuary 2018 | Version 1.0
Health Supplements and Nutraceuticals
Health supplements and Nutraceuticals Compliance Guidance
3
ContentsPreface 5
1. Introduction 6
2. DefinitionandIdentity 8
3. Information on Labels 18
A. Specificlabellingrequirements 20
B. Generallabellingregulationforpre-packagedfoods 26
C. TolerancesandOverages 36
D. Roundingofnumerals 38
4. Composition of Health Supplements and Nutraceuticals 40
A. Vitamins and minerals 42
B. Ingredientsotherthanvitaminsandminerals 45
C. Nutraceuticalasingredients 47
D. Specifications,Quality,Purity 48
E. Food Additives 49
F. IngredientsnotincludedintheSchedules 49
G. Non-specifiedfoods 50
5. Licensing and Import 52
6. GlossaryandAbbreviations 54
Health supplements and Nutraceuticals Compliance Guidance
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Preface
IndiahasimplementeditsfirstregulationforHealthSupplementsandNutraceuticals,from1January2018.Healthsupplementsandnutraceuticalsarefoodproductsthatdiffersignificantlyfromfoodproductsinappearanceandpurposeofuse.Theyarealsoknownasdietarysupplementsorfoodsupplements.
Whilebeingcontrolledbythespecificregulation,healthsupplementsarealsosubjecttoseveralcomplementaryregulationssuchaslabelling,claims,GMP,licensing,importetc.thatfoodbusinessesmustconsiderandcomply.
ThisRecHaNcomplianceguidanceservesasaplaceforfoodbusinessoperatorstofindkeyregulatoryrequirements,similaritiesandwhereindicateddifferenceswithglobalpractice.Thisguidanceprovidesasimplifiedunderstandingoftheregulationbyuseoftextandgraphicstoenableunderstandingataglance.
Itisintendedforallfoodbusinessoperatorsengagedinmanufacturing,import,distributionandsaleofhealthsupplementsandnutraceuticalsaswellasfoodsafetyofficersimplementingtheregulation.Thisguidanceattemptstoencouragedialogueandthefindingofcommongroundbetweenallstakeholdersbasedonglobalpractice,includinggloballyaccepted interpretations.
Theauthorsrecognisethatasisthecasewithmanyfirst-timeregulations,severalinterimandtemporarymeasuresmaybetakenbythecompetentauthoritiestoreducetheburdenofcomplianceduringtheinitialmakeoverofproductsinthemarket.TheFoodBusinessOperatorisrequiredtobecloselyengagedwiththecompetentauthorityandtheissuanceof amendments.
Theauthorsrealisethatseveralmorefacetsoftheregulationremaintobetackled,includingrevisionstothisdocument,andexpecttoreleaseupdatedandnewadditionsattheappropriate time.
Section 1
Introduction
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TheInternationalAllianceofDietary/FoodSupplementsAssociations(IADSA)andConfederationofIndianIndustries(CII)haveestablishedacollaborativeinitiativeundertheResourceCenteronHealthSupplements and Nutraceuticals (RecHaN).
IADSAbringstogetherassociationsfrom6continentsinthefoodsupplementsectortocoordinatediscussionsinCodexAlimentariusandsupportgovernmentsandtheprivatesectoronappropriateandeffectiveregulationandpolicy.Aleadinginternationalexpertassociation,itaimstobuildsciencebasedinteractiveplatformsforpolicymakingandharmonisedapproachestolegislation.
CII(ConfederationofIndianIndustries)apremierbusinessassociationofindustriesservesasareferencepointforIndianindustryandtheinternationalbusinesscommunity.CIIthroughtheFoodandAgricultureCentreofExcellence(CII-FACE)providesanintegratedapproachofaction-orientedprogramsandcapacitybuildingaddressingissuesfromthefarmgatetoconsumers.Itworksinpartnershipwithgovernment,FSSAI,Industryandotherstakeholders.
TheFoodSafetyandStandards(HealthSupplements,Nutraceuticals,FoodsforSpecialDietaryUses,FoodsforSpecialMedicalPurpose,FunctionalFoodsandNovelFood)Regulations,2016,dueforimplementationfrom1stJanuary2018,requiresbusinessestobecomplianceready.Aswithmanyfirst-timeregulations,stakeholdersmay,intheinitialstagesfaceuncertaintywithcompliancerequirementsandrequireongoingguidance.ItisappropriateRecHaNshouldasitsfirstinitiativehelpstrengthencomplianceefforts.
ThisguidanceispreparedbasedonreadingoftheAct;FSSA(2006)andregulations;FoodSafetyandStandards(HealthSupplements,Nutraceuticals,FoodforSpecialDietaryUses,FoodforSpecialMedicalPurpose,FunctionalFoodsandNovelFoods)Regulations2016.Inaddition,thedocumentprovidesguidanceoninternationalregulationandbestpracticewherethiscanprovehelpfulintheprocessofensuringcomplianceinIndia.
Thisdocumentreflectsthebestunderstandingoftheauthorsatthetimeofwritingandhasnolegalbearing,norisitintendedtosubstitutetheimplementationproceduresofthecompetent authority.
Section 2
DefinitionandIdentityofHealth Supplements and Nutraceuticals
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1.HowareHealthSupplementsdefined?
Areadingofsection22oftheFoodSafetyandStandardsAct(FSSA)providesthescopeforuseofthetermHealthSupplements,whichisharmonisedwithglobaldefinitions.
‘Healthsupplement’isdescribedasadietarysubstance(s)forusebyhumanbeingstosupplementthedietbyincreasingthetotaldietaryintake,andmaycontainoneormoreofanyofthefollowingingredients:
(a) plantorbotanicalsortheirpartsintheformofpowder,concentrateorextractsinwater,ethylalcoholorhydro-alcoholicextracts,singleorincombination;
(b) mineralsorvitaminsorproteinsormetalsortheircompoundsoraminoacids,orenzymes,or
(c) substancesfromanimaloriginand
(d) wherebysuchproductsmaybeformulatedintheformofpowders,granules,tablets,capsules,liquids,jellyorotherdosageforms;
andwhicharenotrepresentedforuseasconventionalfoods.
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DefinitionandIdentityofHealthSupplementsandNutraceuticals
2.HowareHealthSupplementsdefinedinothercountries?
ThetermHealthSupplementsisalsousedtorefertothecategoryinASEAN,buttheyarereferredtoasfoodsupplementsintheEUanddietarysupplementsintheUS.Whateverthenameused,theybelongtothefoodcategorynumber13.6oftheglobalFoodCategorySystemusedbyCodexAlimentariusandininternationaltrade.
InASEAN(ASEANAgreementonHeathSupplements),thefollowingdefinitionhasbeen agreed:
“HealthSupplements”meananyproductthatisusedtosupplementadietandtomaintain,enhanceandimprovethehealthyfunctionofhumanbodyandcontainsoneormore,oracombinationofthefollowing:
i. Vitamins,minerals,aminoacids,fattyacids,enzymes,probioticsandotherbioactivesubstances.
ii. Substancesderivedfromnaturalsources,includinganimal,mineralandbotanicalmaterialsintheformsofextracts,isolates,concentrates,metabolites.
iii. Syntheticsourcesofingredientsmentionedin(i)and(ii).
Itispresentedindosageforms(tobeadministered)insmallunitdosessuchascapsules,tablets,powder,liquidsanditshallnotincludeanysterilepreparations(i.e.injectable,eye drops).
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ThedefinitionoffoodsupplementsintheEUisestablishedintheFoodSupplementDirective:2002/46EContheapproximationofthelawsoftheMemberStatesrelatingtofoodsupplements.
‘Foodsupplements’meansfoodstuffsthepurposeofwhichistosupplementthenormaldietandwhichareconcentratedsourcesofnutrientsorothersubstanceswithanutritionalorphysiologicaleffect,aloneorincombination,marketedindoseform,namelyformssuchascapsules,pastilles,tablets,pillsandothersimilarforms,sachetsofpowder,ampoulesofliquids,dropdispensingbottles,andothersimilarformsofliquidsandpowdersdesignedtobetakeninmeasuredsmallunitquantities.
In the US Dietary Supplement Health Education Act (1994) the term ‘dietary supplement’ meansaproduct(otherthantobacco)intendedtosupplementthedietthatbearsorcontainsoneormoreofthefollowingdietaryingredients:
(A) Avitamin;
(B) Amineral;
(C) Anherborotherbotanical;
(D) Anaminoacid;
(E) Adietarysubstanceforusebymantosupplementthedietbyincreasingthetotal dietaryintake;or
(F) Aconcentrate,metabolite,constituent,extractorcombinationofanyingredient describedinclause(A),(B),(C),(D)or(F)andenzymes
Arenotrepresentedforuseasaconventionalfoodorassoleitemofamealorthediet.
Atthegloballevel,adefinitionisprovidedbyCodexAlimentariusonvitaminandmineralfoodsupplements.
GuidelinesforVitaminandMineralFoodSupplementsCAC/GL55-2005:vitaminandmineralfoodsupplementsforthepurposeoftheseguidelinesderivetheirnutritionalrelevanceprimarilyfromthevitaminsand/ormineralstheycontain.Vitaminandmineralfoodsupplementsaresourcesinconcentratedformsofthosenutrientsaloneorincombination,marketedinformssuchascapsules,tablets,powders,solutionsetc.,thataredesignedtobetakeninmeasuredsmall-unitquantitiesbutarenotinaconventionalfoodformandwhosepurposeistosupplementtheintakeofvitaminand/ormineralsforthenormal diet.
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3.ArethedefinitionsofHealthSupplements,FoodSupplementsandDietarySupplementsharmonisedglobally?
Overmanyyears,thedefinitionsofthecategoryhavebecomealigned.Definitionsacrosstheworldincludethefollowingdefinitiveterms;
• Supplementsaredesignedto‘supplement’thediet;
• Theyaremarketedinpre-dosedformssuchastablets,pills,capsules,powders,liquids;
• Theyhaveanutritionorphysiologicaleffect;
• Theyaretakeninsmallmeasuredquantities;
• Theyarenottobepresentedasordinaryorconventionalfoods;
4.HowareHealthSupplementsdistinctfromotherfoodproducts?
IntheFSS(HSN)2016regulationseveralotherfoodcategoriesareincludednamelyfoodsforspecialdietaryuses(FSDU),foodforspecialmedicalpurpose(FSMP).
Asstatedabove,HealthSupplementsarecategorisedinsub-category13.6ofCategory13.0:Foodstuffsintendedforparticularnutrition,oftheCodexFoodCategorySystem(GSFA192:1995)andFSS(FoodProductsStandardsandFoodAdditives)Regulation2011:(7thAmendment,2016).
DefinitionandIdentityofHealthSupplementsandNutraceuticals
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Category13.0containsseveralsub-categories:
HealthSupplementsbelongtosub-category13.6andaredistinctfromotherfoodcategoriesintermsoftheirphysicalformandpurposeofuse.Thesedistinguishablefactorsareextremelyimportantforthepurposeofconsistencyincomplianceandenforcement.
ItistobenotedthatHealthSupplementsarenotsimilartofoodsforspecialdietaryusesorfoodsforspecialmedicalpurposesornormalfoodsasthepurposeofusediffers.
Food Category System 1, 2
13.0 Foodstuffs intended for particular nutrition
13.1 Infantformulas,follow-on,andformulasforspecialmedicalpurposesfor infants
13.1.1 Infantformulas
13.1.2 Follow-upformulas
13.1.3 Formulaforspecialmedicalpurposesforinfants
13.2 Complementaryfoodsforinfantsandyoungchildren
13.3 Dieteticfoodsintendedforspecialmedicalpurposes(excludingproductsoffoodcategory13.1)
13.4 Dieteticformulasforslimmingpurposesandweightreduction
13.5 Dieteticfoods(e.g.supplementaryfoodsfordietaryuses)excludingproductsinfoodcategories13.1,13.4and13.6
13.6 Food Supplements 3
1.FoodCategorySystem:CodexStan192-1995
2.FoodSafetyandStandards(FoodProductStandards&FoodAdditives)Regulations2011;(7th Amendment2016)
3.Productsinthecategory13.6arealsodescribedas‘HealthSupplements’,or‘DietarySupplements’
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5.HowareNutraceuticalsdefined?
FSS(HSN)2016[7(1)(iii)]highlightsthatNutraceuticalsmaybepreparedandsoldinthefoodformatofgranules,powder,tablet,capsule,liquid,jellyorgel,orsemi-solidsandotherformatsandmaybepackedinsachet,ampoule,bottle,andinanyotherformatasmeasuredunitquantitiesexceptthoseformatsthataremeantforparentaladministration.
Foodproductsintendedtosupplementthedietandbemarketedinformssuchascapsules,tablets,powdersorliquidsetc.aredescribedinregulationsworldwidewithasingleterminology.e.g.dietarysupplements,foodsupplementsorHealthSupplements.
• ThedescriptionsofNutraceuticalsandHealthSupplementsaresimilarintermsoftheiridentifyingfeatures;thesesimilaritiesareemphasisedinthedocument.
ThesesimilaritiesbetweenHealthSupplementsandNutraceuticalsareemphasisedinthe document.
DefinitionandIdentityofHealthSupplementsandNutraceuticals
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6.HowareHealthSupplementsdistinctfromnormalfoods?
TwocriteriadistinguishHealthSupplementsandsetthemapartfromnormal (ordinaryorconventionalfoods):
01. Theirmarketableformssuchascapsules,tablets,powdersorliquidstobetakeninsmallmeasuredquantities;
02. Theirpurposeofuseaspresented(declaredas“HealthSupplement”onthelabel);
Insomecaseschallengesmayoccurwithsomefoodsorfoodingredients,whichbeinga normalfoodcanbeidenticalintermsoftheirformtoHealthSupplements.
Forexample;psylliumhuskapopularfood(fiber)marketedforseveralyearsasanormalfoodtobeadded(1-2teaspoons)towater,milk,orporridge,accordingtoinstructionsfor use.
Thesamefiber(psylliumhusk)preparationmayalsobemarketedasaHealthSupplement,beingaconcentratedsourceoffiber,meanttosupplementthedietandmarketedtobetakeninsmallmeasuredquantities;forexample(1-2capsulesaday)orasapowder(1-2 tablespoons).Itthereforecompliesinform.However,itspurposeofuseisthenextcriteriatobefulfilled.TheintendedpurposeofuseinthiscaseisaHealthSupplementandthesameistobedeclaredonthelabel.
SimilarlyaHealthSupplementmaybemarketedintheformofpastilles,softchews,lozenges;butmustmeetallthelabellingdeclarationsprovidedintheregulation,includingpackagingthatsupportsthepurposeofusesuchastheadvisory“Keepoutofreachofchildren”,astheseformsmaybeindistinguishablefromnormalfoodseatenforenjoyment.
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7.HowareHealthSupplementsdistinctfromfortifiedfoodproducts
FortifiedfoodsintermsoftheirphysicalformaremoresimilartonormalfoodsthantoHealthSupplements.Fortifiedfoodsinclude,forexample,milk(VitaminAand/orD),edibleoil(VitaminAand/orD),wheatflour(Iron,folicacid,VitaminB12),maltedbeverages,juices(vitaminC),etc.Theadditionofsomevitaminsandmineralstofoodsmaybemandatoryinthecontextofnationalnutritionalgoals.
FortifiedfoodsarealsoconsumedinlargerquantitiesandaspartoftheconventionaldietunlikeHealthSupplements.Theyplayasignificantroleincontributingtothetotaldailyenergyintake,againunlikeHealthSupplements.Theyaremarketedasnormalorordinaryfoods(milk,edibleoiletc.),andinconventionalfoodforms(beverages,juices,biscuitsetc.).
HealthSupplementsareconsumedinsmallunitquantitiesandnotdesignedtoprovideasignificantamountofenergy.
8.HowareHealthSupplementsdistinctfromfoodsforspecialdietary uses
Foodsforspecialdietaryuses(FSDU)areintendedforvulnerableconsumergroupsandoftenusedtoreplaceall,oneormoremeals.Thesefoodsarespeciallypreparedforthosewithaspecificdietaryneedduetoaphysiologicalconditionordisorderandwhennormalfoodsareincapableofmeetingtheirneeds.
Forexample,speciallypreparedmealsforthoseonweightcontroldiets;providing400kcalor800-1200kcal.Anotherexampleisgluten-freefoodsforpersonswithceliacdisorder.Theyareeateninconventionalfoodforms(biscuits,shakes,soupsetc.).
Sincethesefoodsarerequiredtoprovidethedailydietaryneedsofenergyandmacronutrients,FSDU’sarenotproducedormarketedintheformoftablets,capsulesetc.;foodsintheseformsareconsideredhealthsupplements.
DefinitionandIdentityofHealthSupplementsandNutraceuticals
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9.HowareHealthSupplementsdistinctfromfoodsforspecialmedicalpurpose?
TheregulationFSS(HSN)2016recognisesthisspecialcategoryoffoodsdesignedforamedicalpurposeforaparticulartargetgroup,whomayrelyontheseproductsfortheirsolesourceofnutrition.
TheregulationsetstheminimumandmaximumrequirementsforvitaminsandmineralsforFSMP(ScheduleIII)oftheFSS(HSN)2016whichissuitableforuseasthesolesourceofnutritionandensurestheirnutritionneedsaremet.Foodsmarketedas“FoodsforSpecialMedicalPurpose”haverestrictedaccessastheyarelabelled“RECOMMENDEDTOBEUSEDUNDERMEDICALADVICEONLY”andthosewhousethemneedmedicalsupervision.
10.HowareHealthSupplementsdistinctfrommedicinalproducts?
HealthSupplementsarenotintendedtodiagnose,treat,mitigateorprevent,anydiseaseordisorderinhumanbeingsandarenottobemarketedorpresentedorclaimedashavingsuch properties.
EventhoughHealthSupplementssharesomeofthemarketableformsofdrugs,suchascapsules,pills,tabletsetc.theyarecloselyregulatedintermsofthenutritionalandhealthclaimstheymayincludediseaseriskreductionclaims.Foodsproductsareprohibitedfrommakingclaimsthatsuggestorimplythattheycandiagnose,treat,mitigateorpreventadisease or disorder.
AdditionallyeverypackageofHealthSupplementsmustbelabelled “HEALTHSUPPLEMENT”and“NOTFORMEDICINALUSE”
Section 3
InformationonLabels
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Labellingrequirements
Applicableto
Health Supplements Nutraceuticals
Labellingof“HealthSupplements”and“Nutraceuticals”issubjecttocompliancewiththefollowingregulations:
(a) CompliancewiththespecificrequirementsundertheFoodSafetyandStandards(HealthSupplements,Nutraceuticals,FoodsforSpecialDietaryUses,FoodsforSpecialMedicalPurpose,FunctionalFoods,NovelFoods)Regulation2016.
(b) Compliancewiththegenerallabellingregulationrequirementsforpre-packagedfoods;FoodSafetyandStandards(PackagingandLabelling)Regulation2011.1 Under 2.2.1.1:GeneralRequirements“everypre-packagedfoodshallcarryalabelcontaininginformationasrequiredhereunderunlessotherwiseprovided”;
(c) TheFBOisadvisedtoalsofollowtherequirements,asapplicable,undertheLegalMetrology(PackagedCommodity)Rules2011andamendmentsthereto.
Additionally,theFBOisresponsibleforprovidingsufficientinformationonthenatureandpurposeoftheproductalongwithdetailedinstructionsandprecautionsforitsuse,thetargetconsumergroupitaddressesandrecommendeddurationofuse.
1. ThegeneralregulationonlabellingisunderreviewandFoodBusinessOperatorsshouldrefertotheregulationinforceatthetimeofmarketingtheproduct
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A.Specificlabellingrequirements–FSS (HSN) 2016AccordingtotheFSS(HSN)2016:((6(3)(iii)and7(4)(iii))thelabellingofHealthSupplements andNutraceuticalsshouldprovidethefollowinginformation.
1.Nameofthecategory
Applicableto
Health Supplements Nutraceuticals
Thecategorynameunderwhichtheproductissoldshallbe“HEALTHSUPPLEMENT”or“NUTRACEUTICAL”asapplicable.
Global Practice
National terminology
India Canada China Korea USA Russia
Health Supplement
+
Nutraceutical
Natural Health Product(NHP)
Health Food Health Functional Food (HFF)
Dietary Supplement
BiologicallyActive Supplement (BAS)
National terminology
ASEAN EuropeanUnion PacificAlliance
Health Supplement Food Supplement Food Supplement
InformationonLabels
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2. The common name
01. ThecommonnameoftheHealthSupplementorNutraceuticalsshouldbeadescriptionsufficienttoindicatethetruenatureoftheproduct,includingthecommonnamesofthecategoriesofnutrientsorsubstancesthatcharacterisetheproduct.Itisimportanttonotethattheoverridingprincipleisthatthenameordescriptionoftheproductshouldbesufficientfortheconsumertomakeaninformedchoice.
02. Examplesofcategoriesofnutrientsorsubstancesthatcharacterisetheproduct:
e.g.aminoacidsandbotanicals.
03. Severalcategoriescouldbeusedtocharacterisetheproduct:
e.g.HealthSupplementswithvitamins,mineralsandaminoacids.
3.Nutritionlabelling
Applicableto
Health Supplements Nutraceuticals
TheamountofnutrientsorsubstanceswithanutritionalorphysiologicaleffectpresentintheproductshallbedeclaredasprovidedunderFSS(HSN)2016[6(3)(iii)(c)and[7(4)(iii)(c)].
01. ThoughnotspecificallystatedthisinformationconstitutestheNutritionInformationrequiredtobeprovidedtoconsumersinthesamewaythatregulation[FSS(PL)2011(2.2.2.3)]requiresitforgeneralfoods.
02. InformationmaybeprovidedinaNutritionInformationpanel.
03. Theinformationshouldbeconsistentwiththecategorydefinitionofprovidingconcentratedsourcesofsubstancestobetakeninsmallmeasuredquantitiesandinformssuchascapsules,tablets,powdersorliquids.
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04. Thenutritioninformationshouldthereforebeonaperservingbasis[andnotper100gor100mlastheseproductsareconsumedonaservingordosebasis.
Iftherecommendedamounttobetakenperday-morethan1unit(e.g.1tablet,capsulesetc)–itisgoodpracticethatthedeclarationoftheservingsizeshouldreflectthemaximumamounttobetakenperday(e.g.thenumberoftabletsorcapsules)asrecommendedonthelabel.
e.g.Iftherecommendedserving(dosage)onthelabelis1-3tabletsperday,theservingsizeinthenutritionpanelwillbe3tablets.
05. Themannerofsuchadeclaration,(i.e.perserving)-accordingtoFSS(PL)2011[2.2.2.3(v)]whichstatesthat“wherethenutritiondeclarationismadeperserving,theamountin(g)or(ml)shouldbeincludedforreferencebesidetheservingmeasure”,–e.g.givenbelow;
i. 1capsule(200mg)
ii. 1scoop(28g)
iii. 1 teaspoon (5ml)
iv. Therecommendeddailyconsumptionoftheproduct(dose)recommendedbytheFoodBusinessOperatorshouldbeclearandconsistenttotheconsumer.
Global Practice
DietarySupplements/HealthSupplementsaregenerallyexemptedfromthenutritiondeclarationper100gor100ml(e.g.ASEAN,USA,EuropeanUnion)
InformationonLabels
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06. Quantityofnutrients[FSS(HSN)2016[6(3)(iii)(e)and[7(4)(iii)(d)] 1
Applicableto
Health Supplements Nutraceuticals
Whereapplicabletheamountofnutrientsmustbeexpressedasapercentageoftherelevantrecommendeddailyallowances(RDA)asspecifiedbytheIndianCouncilofMedicalResearch(ICMR)andwherethesearenotspecifiedbyICMR,theNRVprovidedbyCodexAlimentariusapply.
ThisrequirementistypicallytobeprovidedintheNutritionInformationpanelwhichisaspecificrequirementforHealthSupplementsandNutraceuticals;FSS(HSN)2016[6(3)(iii)(e)] and [7(4)(iii)(d)].
Global Practice
UnderGlobalPracticethisrequirementofdeclarationofpercentageofRDAforthenutrientissupportedbythedefinitionof‘nutrients’:
• CodexGuidelinesonnutritionlabelling:CAC/GL/2-1985:
– Nutrientmeansanysubstancenormallyconsumedasaconstituentof food:
(a) whichprovidesenergy;or
(b) whichisneededforgrowth,developmentandmaintenanceoflife;or
(c) adeficitofwhichwillcausecharacteristicbio-chemicalorphysiologicalchangestooccur.
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WherenoRDAissetbyICMR,thepercentageofthenutrientdeclaredshouldbebasedon theNRVprovidedbyCodex.
Vitamins ICMR(RDA) Codex(NRV) Minerals ICMR(RDA) Codex(NRV)
VitaminA(retinol) 600μg
VitaminA(β–carotene) 4800μg Calcium 600mg
Vitamin B1 1.2mg Chloride
Vitamin B2 1.4mg Chromium 33μg
VitaminB6(pyridoxine) 2mg Copper 1.35mg
Vitamin B12 1μg Iodine 150μg
Vitamin C 40mg Iron 17mg
Vitamin D 10μg Magnesium 340mg
VitaminE 7.5–10mg Manganese 2-5mg
Vitamin K 55μg Molybdenum
VitaminK2(MK-7) Phosphorus 600mg
VitaminK3(MK-4) Potassium 3750mg
Biotin 30μg Selenium 40ug
Folatedietary 120μg Sodium 2092mg
Niacinequivalent 16mg Zinc 12mg
Pantothenic acid 5mg Boron
Reference to clause 6.2 (iii)
• RDAsetbyICMRformanofsedentarywork:NutrientrequirementsandrecommendeddietaryallowancesforIndians(FinalDraft)2009.
• NRVprovidedbyCodex:Guidelinesonnutritionlabelling(CAC/GL2-1985)
InformationonLabels
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Advisories
07. Anadvisorywarning‘NOTFORMEDICINALUSE’prominentlywrittenFSS(HSN)2016[6(3)(iii)(d)]and[7(4)(iii)(f)]
08. A statement that the product should not beusedasasubstituteforavarieddietFSS(HSN)20166(3)(iii)(f)
09. Awarningoranyotherprecautionstobetakenwhileconsuming,knownsideeffects,ifanyFSS(HSN)2016 [6(3)(iii)(g)]and[7(4)(iii)(h)]
e.g.Donotuseifpregnantandnursing
10. AstatementthattheproductisrequiredtobestoredoutofreachofchildrenFSS(HSN) 2016 [6(3)(iii)(h)] and [7(4)(iii)(i)]
11. Productsshouldbearthewarning‘nottoexceedthestatedrecommendeddailyusage’.FSS(HSN)2016[6(3)(iii)(e)]and[7(4)(iii)(d)]
12. Inthecaseofvitaminsandminerals,theactivityofthecompoundsmustalsobetakenintoaccountandindicatedforthecharacteristicsubstancesastheproportionwithphysiologicalactivity
e.g.thiaminehydrochloridemustbeindicatedasfree-formthiamine).
Applicableto
Health Supplements Nutraceuticals
Applicableto
Health Supplements Nutraceuticals
Applicableto
Health Supplements Nutraceuticals
Applicableto
Health Supplements Nutraceuticals
Applicableto
Health Supplements Nutraceuticals
Applicableto
Health Supplements Nutraceuticals
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B.Generallabellingrequirementsforpre-packagedfoodsFSS(PL)20112
1.ListofIngredients:FSS2011(2.2.2.2.(c))
Applicableto
Health Supplements Nutraceuticals
01. Thelistofingredientsshouldbedeclaredunderanappropriatetitlee.g.“Ingredients”.
02. Allingredientsmustbelistedbyweightindescendingorderinaccordancewiththeformula,exceptfore.g.waterandothervolatilesubstances,whicharelistedinorderoftheirweightinthefinishedproduct.
03. ItisalsorecommendedthatvitaminsandmineralsbeindicatedinthelabellingusingthenameslistedinScheduleIFSS(HSN)2016e.g.vitaminC.Thenameofthenutrientcanalsobesupplementedwiththenameofthenutrientcompound,e.g.vitaminC(ascorbicacid).
04. Regardingtheuseofthenamesofbotanicalsinthelistofingredients,thecommonnameasspecifiedinScheduleIVofFSS(HSN)2016shouldbeused.Itisalsoadvisabletousethefullscientificnameofthebotanical(botanicalfamily+species,e.g.Acacia arabica).
05. FoodadditivesshouldbedeclaredwiththeirfunctionalclassandspecificnameorINS number.
InformationonLabels
2.ThegeneralregulationonlabellingisunderreviewandFoodBusinessOperatorsshouldrefertotheregulationin forceatthetimeofmarketingtheproduct.
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06. Theindicationofingredientscausingallergiesorintolerances,whilenotspecificallyprovidedintheregulationshouldalwaysbedeclaredasaconcernfortherisktheymayprovidetocertainindividuals.Theymaybeemphasisedinthelistofingredientsbyusingadifferentfontsizeorstyleorabackgroundcolourforexample.
e.g.wheyprotein,casein,lecithin,fishoil
Ingredients causing allergies or intolerances
(i) Cerealscontaininggluten;i.e.,wheat,rye,barley,oats,speltortheirhybridisedstrainsandproductsofthese
(ii) Crustacean and their products
(iii) MilkandMilkproducts
(iv) Eggsandeggproducts
(v) Fishandfishproducts
(vi) Peanuts,treenutsandtheirproducts
(vii) Soybeansandtheirproducts
(viii) Sulphiteinconcentrationofmaximum10mg/kg
07. Wheretheingredientorcategoryofingredientsisemphasisedonthelabellinginwords,picturesorgraphics,thepercentageoftheingredient/categoryofingredientsshouldalsobedeclarednexttotheingredientsinthelistofingredients.FSS(PL)2011(2.2.2.(f)).Theamountisdeclaredasapercentage.
08. Generallyaspecificnameshouldbeusedforingredients;howeveracategoryorclasstitlemaybepermittedFSS(PL)2011(2.2.2.2(c))e.g.
• All vitamins as “Vitamins” (class title)
• Allmineralsandtraceelementsas“Minerals”(classtitle)
09. Whilenotspecifiedintheregulation–itisgoodpractice–whenacategoryofingredientsisdeclareditisfollowedby,(inbrackets)theindividualingredientsinthecategorydeclaredindescendingorder.Forexample
• Vitamins(VitaminC,VitaminA,VitaminE)
• Minerals’(Calcium,Iron,Zinc)
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2.Nutritionalinformation
01. Nutritioninformationistobegivenfornutrientsorsubstancespresentintheproduct,whichprovideanutritionalorphysiologicaleffect.
02. Unlessproteins,fatsorcarbohydratesareaddedtoHealthSupplementsornurtraceuticalsonavoluntarybasisfornutritional/physiologicalpurposes,goodpracticewouldbetoexemptthelabellingofthesemacronutrientsandenergyintakefromthenutritionalinformationprovidedtheydonotcontributesignificantlytothedailyfoodintake.
Global Practice
IntheUSA,dietaryingredientsthatcontributeamountsinexcessofthelistedamounts(basedononeserving,asindicatedinthetablebelow)mustbedeclaredontheproductlabel.Iftheproteincontentiscomposedonlyofindividualaminoacids,thesemustbelisted separately and not as protein.
*DV= Daily Value
Category Amount
Total calories 5kcal
Caloriesfromfat 5kcal
Totalfat 0.5g
Saturatedfat 0.5g
Cholesterol 2mg
Sodium 5mg
Totalcarbohydrate 0.5g
Dietaryfiber 0.5g
Sugars 0.5g
Protein 0.5g
Vitamin A 2% DV
Vitamin C 2% 0V
Calcium 2% DV
Iron 2% 0V
InformationonLabels
Health supplements and Nutraceuticals Compliance Guidance
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03. NutritionalInformationornutritionalfactsper100gor100mlisnotapplicable.
04. Theamountofanyothernutrientforwhichanutritionorhealthclaimismade:
• Whenahealthclaimismadetheamountofthenutrientforwhichtheclaimismadeisrequiredtobelisted.Whentheclaimrelatestothetypeoffattyacid,theamountofsaturatedfattyacid,monounsaturatedfattyacidandpolyunsaturatedfattyacid,transfatsin(g)andcholesterolin(mg)aretobedeclared.
05. Forvitaminsandmineralstheamountshallbedeclaredinmetricunits(gramormilligramormicrogram).ThisisprovidedintheTableonRDAabove.
3. Name and complete address
01. Thenameandcompleteaddressofthemanufacturer;andwherethemanufacturerisnotthepackerorbottlerthenameandcompleteaddressofthebrandowneralongwiththelicencenumberofthepackingorbottlingunit.
02. Theaddressshallbeprecededbythewords“Manufacturedby”or“Mfg.by”or“Mfd.by”orPkd.by”or“Marketedby”or“Mktby”or“Importedby”.
03. WherethefoodisimportedintoIndia,thepackageshallalsocarrythenameandcompleteaddressoftheimporterinIndia.IfthefoodismanufacturedoutsideIndiaandthereafterpackedandbottledinIndia,thepackageshallalsobearthenameofthecountryoforiginandthenameandcompleteaddressoftheimporterandthepremisesofpackingorbottlinginIndia.
04. TheFSSAIlogoandlicencenumbershallbedisplayedagainstacontrastingbackgroundonthelabelofthefoodpackageasbelow(refertoOrderdated10th February2017fordetails).
Lic. No XXXXXXXXXXXXXX
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4.NetQuantity
Netquantitybyweightorvolumeornumber,asthecasemaybe,shallbedeclared.
01. UndertheLegalMetrologyActeveryunitofweightormeasureshallbeinaccordancewiththeMetricSystemontheInternationalSystemofUnits.Everynumerationshallbemadeinaccordancewiththedecimalsystem.
02. Forfoodproductssoldbynumber,thenumberdeclaredshouldbefollowedbythesymbolNorU:
• e.g.100capsulesmaydeclaredas:NetQuantity:100Nor100U3
03. Theheightofthenumeralandletterwhenthenetquantityisinweight,volumeornumberdeclaredontheprincipaldisplaypanel(PDP)ofthepackageaccordingtorecentamendmentunderLM(PCR)2017[7(2)] 3isgivenbelow:
Table I: Minimum height of numeral
SI. No. AreaofPDPin squarecentimeters(A)
Minimum height of numerals and letters in millimeters
Normal Whenblown,formed,mouldedonsurfaceofcontainer.
(1) (2) (3)
1 A≤50 1.0 1.5
2 50<A≤100 1.5 3.0
3 100<A≤500 2.5 4.0
4 500<A≤2500 4.0 6.0
5 2500 > A 6.0 6.0
InformationonLabels
3.LegalMetrology(PCR)2011andamendmentsLM(PCR)2017
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5.Lot/Code/BatchIdentification
Thebatch/codeorlotnumberisamarkofidentificationbywhichthefoodcanbetracedinmanufactureandidentifiedindistributionoftheproductshouldbegivenonthelabel.
6.Instructionforuse
Instructionsforuse,includingreconstitutionwhereapplicable,shallbeincludedonthelabelifnecessarytoensurecorrectutilizationofthefood,orotherdirectionsforpurposeofqualityandsafetyofthefood(e.g.“refrigerateafteropening”,oneeffervescenttabletadaytobedissolvedinaglassofwater).
Global Practice
USA:Thenetquantityofcontentsstatementmustbeexpressedeitherinweightormeasure,numericalcount,oracombinationthereof(e.g.“60capsules”or“90softgels–1,000mg”).Ifthequantityisprovidedinweightormeasure,itmustbeexpressedusingbothmetricunitsandtheU.S.customarysystem(e.g.“netwt.18 oz.(510g)”).
EU:InmostEUMemberStates,thenetquantitymustbeexpressedinnumericalcount,(e.g.“60capsules”)incombinationwiththeweightormeasureexpressedusingmetricunits.
ASEAN:Thenetcontentsshallbedeclaredinthemetricsystem.Thenetcontentsshallbedeclaredinthefollowingmanner:-Forliquidform,byvolume;-Forsolidformsuchastablet,softcapsule,hardcapsule,powder,etc.byweightoramount;-Forsemi-solidorviscousform,eitherbyweightorvolume.
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7.DateofManufactureorPacking
01. Thedate,monthandyearinwhichthefoodismanufactured,packedorpre-packed,shallbegivenonthelabelinaccordancewiththeapplicablebestbeforedate(BBD);as below:
02. WhentheBBDofthefoodismorethan3months,onlythemonthandyearofmanufacture,orpackingshouldbedeclared.
03. WhentheBBDofthefoodislessthan3monthstheday,thedate,monthandyearinwhichtheproductismanufactured,preparedorpre-packedshouldbegiven.
8.SizeofLetter/Numerals
01. Theheightoflettersshallnotbelessthan1mmandwhenblown,formed,moulded,embossedorperforated,itshallnotbelessthan2mm;
02. Thewidthoftheletterornumeralshallnotbelessthanone-thirdofitsheightbutthisprovisionshallnotapplyincaseofthenumeral“1” and letters “i” “I” and “l”
03. Incaseofdeclarationofnetquantity(weight,volumeornumber),theheightofnumeralsisgivenaboveundernetquantity(seetable).
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Health supplements and Nutraceuticals Compliance Guidance
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9.BestBeforeDate(BBD)
01. Generallabellingregulationsregardingthetimeindicationunderspecifiedstorageconditionsistobegivensothatmeasuredvaluesofnutrientsandsubstancesshouldbewithinthetolerancesaroundthedeclaredvalueduringtheentireshelflife.
02. ThetimeindicationmaybeprovidedeitherastheBestBeforeDate(BBD)ortheExpiry/Lastconsumption/Usebydate,asapplicable.TheBBDistobeprovidedasgiveninthe regulation;
Themonthandyearshallbedeclaredincapitalletters;
BESTBEFORE declare MONTHANDYEAR e.g.JUN 2018
OR
BESTBEFORE declare MONTHSFROMPACKAGINGORMANUFACTURING
e.g.BESTBEFORE10 MONTHSFROMMANUFACTUREORPACKING (as applicable)
OR
BESTBEFORE declare DAYSFROMMANUFACTURE
e.g.14DAYSFROMMFD
Monthandyearmaybegiveninnumerals;andyearmaybegivenintwodigits.
Global Practice
‘StabilityTestingforShelfLifeDeterminationofSupplements’ispartofaseriesofTechnicalGuidanceforthesupplementindustry,whichhavebeenproducedbytheIADSATechnicalGroupoverthepastfewyears.‘StabilityTestingforShelfLifeDeterminationofSupplements’outlinestheprinciplesforsettingupscientificallybasedstabilitystudies,whicharespecificallydesignedtoassessthestabilityandpotentialshelflifeofsupplements.Itdiscussesthevariousimportantaspectsthatneedtobetakenintoconsiderationwhendesigningastability study.
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10.DeclarationofVegetarian/Non-vegetarianLogo:
01. Underregulation2.2.2.4ofFSS(PL)2011everypackageoffoodshallbearadeclarationonthelabelbysymbolandcolourtoindicatewhetherthefoodisVegetarianorNon-vegetarian.
02. Thesizeofthelogoisdeterminedonthesizeoftheprincipaldisplaypaneloftheproductanddetailsprovidedintheregulation.
03. Thesymbol(logo)shallbeplacedontheprincipaldisplaypanelofthepackage,incloseproximitytothenameorbrandnameoftheproduct.
04. Itshallalsoappearinpamphlets,leafletsandadvertisementsinanymediausedinrelation to the product.
11.PrincipalDisplayPanel(PDP)
UnderthegenerallabellingregulationFSS(PL)2011thefollowingmandatorydeclarations shouldbegivenonthePDP.
01. Definition:“PrincipalDisplayPanel”meansthatpartofthecontainer/package,whichisintendedorlikelytobedisplayedorpresentedorshownorexaminedbythecustomerundernormalandcustomaryconditionsofdisplay,saleorpurchaseofthecommoditycontained therein.
02. ThefollowingdeclarationsaretobemadeonthePDP;
• NameofFoodProduct
• NetQuantity:weight,volumeornumberasapplicable
• Veg/NonVegLogo
InformationonLabels
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12.CountryofOriginforImportedFoods
01. Thecountryoforiginofthefoodshallbedeclaredonthelabeloffoodimportedinto India.
02. Whenthefoodundergoesprocessinginasecondcountry,whichchangesitsnature,thecountryinwhichtheprocessingisperformedshallbeconsideredtobethecountryoforiginforthepurposeoflabelling.
13.AdvisoriesandWarnings
01. TheFBOisadvisedtorefertothegenerallabellingregulationsFSS(PL)2011andthespecificlabellingrequiredforHealthSupplementsandNutraceuticalsFSS(HSN)2016,forspecialdeclarationsregardingadvisoriesorwarningsornon-recommendations;
02. Undergenerallabellingregulationsthefollowingwarningsarerequired,whensuchingredientsorsubstancesarepresentinthefood:
• Whenafoodpackagecontainspolyols;declarationsurroundedbyandenclosingline(boxed)
POLYOLSMAYHAVELAXATIVEEFFECT
• Whenafoodpackagecontainspolydextrose;declarationsurroundedbyanenclosingline(boxed)
POLYDEXTROSEMAYHAVELAXATIVEEFFECT
• Whenafoodpackagecontainsaddedcaffeine;declarationsurroundedbyanenclosingline(boxed);providedalsothatthequantityofcaffeineisdeclaredinthelistofingredients
CONTAINS ADDED CAFFEINE
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C.TolerancesandOverages
Applicableto
Health Supplements Nutraceuticals
01. TheregulationFSS(HSN)2016providesageneraltolerancelevelofallarticlesoffoodcoveredintheregulationpertainingtoanalyticalvariationsoffinishedproducts.Theminimumtolerancefortheamountofnutrientsorsubstancesdeclaredshouldnotbelessthan90%ofthedeclaredlabelvalue.
02. Overagesforvitaminsandminerals:ScheduleITableCprovidestheamountsofoveragesforalistofvitaminsandincasethesearenotprovided,overagesusedshouldbebasedonaproperscientificassessmentoftheamountthatmaybe required.
03. Overagesareaprovisionmadefortheadditionofanexcessamountofnutrientsaddedabovethelabeldeclarationduringmanufacturetomaintaintheclaimedamountforthestatedshelflifeoftheproducttocompensatefortheexpectedmanufacturing/storagelossandtoallowforvariationinassays.Whereoveragesaremorethanthoselisted,properjustificationshouldbeprovided.
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Health supplements and Nutraceuticals Compliance Guidance
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Table C: Permissible overages*
S. No. Micronutrient Overages (percent)
1 Vitamin A 30
2 Vitamin C 20
3 Vitamin D 30
4 Vitamin E 10
5 Thiamine (Vitamin B1) 25
6 Riboflavin(VitaminB2) 25
7 Niacin (Vitamin B3) 10
8 Vitamin B6 25
9 Vitamin B12 25
10 Folic acid 25
11 Pantothenicacid 10
12 VitaminK1 30
13 Minerals 10
14 Iodine 20
*Overagemeanstheamountofexcessnutrientsaddedabovelabelclaimduringmanufactureasameansofmaintainingatleasttheclaimedamountoftheingredient(s)forthenormalshelflifeoftheproducttocompensatefortheexpectedmanufacturing/storagelossandtoallowforvariationinassayperformance.WhereoveragesaremorethanthoselistedinScheduleITableC,thesameshallbescientificallysubstantiated.
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D.RoundingofnumeralsWhilenotspecifiedinFSS(HSN)2016,itisgoodpracticetoproviderelevantandaccurateinformationtoconsumers.Roundingmeansmakinganumbersimplerbutkeepingitsvalueclosetowhatitwas.
Forthepurposeoftheamountsofnutrientsdeclaredinthenutritioninformationtable,theroundingmaybeprovidedinaccordancetotheIndianStandard:Rulesforroundingoffnumericalvalues:IS:2-1960(Reaffirmed2000)Edition2.3(2000-08)oftheBureauofIndian Standards.
Rule I—Whenthefigurenextbeyondthelastfigureorplacetoberetainedislessthan5,thefigureinthelastplaceretainedshallbeleftunchanged.
Rule II—Whenthefigurenextbeyondthelastfigureorplacetoberetainedismorethan5oris5followedbyanyfiguresotherthanzeros,thefigureinthelastplaceretainedshallbeincreasedby1.
Rule III—Whenthefigurenextbeyondthelastfigureorplacetoberetainedis5aloneor5followedbyzerosonly,thefigureinthelastplaceretainedshallbe(a)increasedby1 ifitisoddand(b)leftunchangedifeven(zerowouldberegardedasanevennumberforthis purpose).
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Health supplements and Nutraceuticals Compliance Guidance
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Examples of rounding off values to unit fineness
Value Fineness of rounding
1 0.1 0.01 0.001
Rounded value
Rule Rounded value
Rule Rounded value
Rule Rounded value
Rule
7.2604 7 I 7.3 II 7.26 I 7.260 I
14.725 15 II 14.7 I 14.72 III 14.725 –
3.455 3 I 3.5 II 3.46 III 3.455 –
13.545001 14 II 13.5 I 13.55 II 13.545 I
8.725 9 II 8.7 I 8.72 III 8.725 –
19.205 19 I 19.2 I 19.20 III 19.205 –
0.5499 1 II 0.5 I 0.55 II 0.550 II
0.6501 1 II 0.7 II 0.65 I 0.650 I
0.04950 0 I 0.0 I 0.05 II 0.050 III
Section details
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Section 4
CompositionofHealth Supplementsand Nutraceuticals
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HealthSupplementsorNutraceuticalscompriseingredients(includingvitaminsandminerals)thatprovidenutritionalandphysiologicaleffect,andothersubstances,suchasadditives,requiredinpreparationoftheproducts.
Theingredientsincludevitaminsandminerals,plantandbotanicals,herbs,othersubstancesfromplantandanimalsources,aminoacids,proteins,dietaryfats,fattyacids,carbohydrates,probioticsenzymeetc.
Note:AsperFSS(HSN)2016[GeneralRequirements3(21)]productsconsistingofvitaminsand/ormineralsonlyshouldnotbemarketedasHealthSupplementsorNutraceuticals.Thissub-regulationisundernoticeforsuggestions,viewsand comments.1
ThisprovisionconflictswithCodexGuidelinesforVitaminandMineralFoodSupplements(CAC/GL55–2005)andprovisionsincountries/regionshavingregulationinplaceforfoodsupplements,dietarysupplementsorHealthSupplements.Itislikelytocreatebarrierstotrade.
1.Noticeforsuggestions,views,commentsondraftFSS(HSN)Amendment2018dated09.01.2018.
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CompositionofHealthSupplementsandNutraceuticals
A. Vitamins and minerals
1. Forms and sources
Applicableto
Health Supplements Nutraceuticals
VitaminsandmineralslistedinScheduleI(TablesA,B)ofFSS(HSN)2016maybeaddedtoHealthSupplementsorNutraceuticalsandintheformslistedtherein.TheRegulationisamendedfromtimetotimeasneeded.
Itshouldbenotedthat“HemeIron”shallnotbeusedasasourceofIron(Fe)inanyforminanyarticleoffood–asperdirectionoftheFSSAIdated31March2017.
Global Practice
ThelistofvitaminsandmineralsgiveninScheduleITableAandBaresimilartothoseprovidedintheEUDirective2002/46/EContheapproximationofthelawsoftheMemberStatesrelatingtofoodsupplements.
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2.Maximumlimitsforadditionofvitaminsandminerals
Applicableto
Health Supplements Nutraceuticals
01. InaccordancewithFSS(HSN)2016[GeneralRequirements3(4)],thequantityofnutrientsaddedtohealthsupplementsornutraceuticalsshouldnotexceedtherecommendeddailyallowance(RDA)specifiedbytheIndianCouncilofMedicalResearch(ICMR),andwherethesearenotlaiddown,theNRVprovidedbyCodexAlimentariusCommissionshouldbeused(refertoTableinSection2).
02. ThemaximumamountsofvitaminsandmineralsinhealthsupplementsneedtobesettakingintoaccounttheuppersafelevelsestablishedbytheICMRusingariskmanagementbasedapproachinaccordancewithglobalpractice.
Global Practice
CodexGuidelinesforVitaminandmineralsfoodsupplements(CAC/GL55-2005Section3.2)providesguidelinethat“themaximumamountsofvitaminsandmineralsinvitaminandmineralfoodsupplementsperdailyportionofconsumptionasrecommendedbythemanufacturershallbesettakingthefollowingcriteriainto account:
(a) uppersafelevelsofvitaminsandmineralsestablishedbyscientificriskassessmentbasedongenerallyacceptedscientificdata,takingintoconsideration,asappropriate,thevaryingdegreesofsensitivityofdifferentconsumergroups;
(b) thedailyintakeofvitaminsandmineralsfromotherdietarysources.”
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Status of vitamins and mineral maximum levels (2017)
RDAbasedlevels Countriesmovingtosafetybasedlevels Safetybasedlevels
CompositionofHealthSupplementsandNutraceuticals
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B.Ingredientsotherthanvitamins and minerals
01. FSS(HSN)[6(1)(i-iii)and[7(1)(i-iii):TheseregulatoryclausesgivetherequirementsregardingthecompositionandformforHealthSupplementsandNutraceuticalsrespectively.HealthSupplementsorNutraceuticalsshallcontainingredientsspecifiedinthetable.
Ingredients Schedule No Health Supplements Nutraceuticals
VitaminsandMineralsandtheirforms I
Amino acids II
Plantorbotanicalingredients IV
Nutraceuticalsasingredients VI
ONLYENZYMES
Probiotic VII
Prebiotics VIII
02. ScheduleIVFSS(HSN)2016listsplantsandbotanicals,whichmaybeused.
03. Theymaybeusedtosupplementthenormaldietofapersonabove5yearsofage [6(1)(i)].Howeverforusebychildrenbelowtheageof5,theproductshallbegivenonlyundermedicaladvicebyphysician/certifieddietitican/nutritionist.4
04. Plantsandbotanicals,andtheirpartsthatmaybeusedinHealthSupplementsandNutraceuticalsareprovidedintheSchedule,withcertainclarificationsundertheNotes.
4.Noticeforsuggestions,views,commentsondraftFSS(HSN)Amendment2018dated09.01.2018
46
05. ApermittedrangeisindicatedforeachentryintheSchedule,withrecommendationsin certaincasese.g.
Name(Latin) Part Common or vernacular name
Permittedrange: adult/dayasrawherb
Abelmoschus esculentus (L.) Moench
Fruit/root Bhindi 5-10g(aspowder)
Camellia sinensis Tealeafextract Chaya 1-2gNot recommended for childrenbelow5y
Tea catechins Green tea 0.5-1.0g
Crocus sativus L Styleandstigma kumkum(Kesar) 25-50gNot recommended for childrenbelow16y
Daucus carota L. Seed Gajar 1-2g(aspowder)Not recommended duringpregnancy
Itisalsoclarifiedthatiftheingredientusedintheproductisanextract,itsquantityshouldbetheequivalentofextractivesobtainedfromusingtherawplantorbotanicalintherangesprovidedinthelastcolumnoftheTableofScheduleIV.
CompositionofHealthSupplementsandNutraceuticals
Note1:TheingredientslistedintheScheduleshouldbeusedafterdueprocessingorintheirextractformssubjecttobeingusedwithinthepermissiblerangeindicatedinthelastcolumnoftheTableofSchedule IV.
Note2:TheingredientsshallcomplywithFSS(Contaminants,ToxinsandResidues)Regulation2011,andtheirproductsshallcomplywiththelimitsprovidedfor“foodsnotspecified”.
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C.NutraceuticalasingredientsScheduleVIprovidesalistofNutraceuticalsasingredients,includingenzymes.It consists oftwoparts;
• Part,Awhichlists,recommendedusage(minimumandmaximum)perday;
• InPartBoftheSchedule,theusagelevelshavenotbeenprovidedandtheseshouldbebasedonrelevantscientificdataonsafetyandefficacioususe,whichshouldbeprovidedtotheAuthorityorduringlicensingwhenrequired;
• ForaproducttobelabelledNutraceuticals,itmustcontainoneormoreingredientsfromScheduleVI(Nutraceuticalsasingredients)andmaycontainpermittedingredientsfromotherSchedules.
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CompositionofHealthSupplementsandNutraceuticals
D.Specifications,Quality,PurityTheregulationdoesnotprovidespecificationrelatingtopurityforingredientsortheirsourcelistedinScheduleII,IV,VI(enzymesonly),VII(probioticsandVIII(prebiotics).
• However,ingredientsorsubstances(e.g.foodadditives)usedinHealthSupplements,shouldprimarilycomplywithspecificationsandstandardsprovidedintheapplicableFSSregulations;namely
• FSS(FoodProductStandardsandFoodAdditives)Regulation2011;
• FSS(FoodProductStandardsandFoodAdditives)Regulation2011: (7thAmendment2016);
• FSS(HealthSupplements,Nutraceuticals....)Regulation2016-[FSS(HSN)2016].
TheregulationFSS(FPS/FA)2011,containsspecificationsrelatingtocertainfoodsandfoodadditives,andtheseshouldbecompliedwithifsuchsubstancesareused;
• Wherespecificationsforingredients,vitamins,minerals,foodadditivesorothersubstancesusedarenotprovidedinFSSregulations,theFBOmayrelyuponauthoritativeandinternationallyrecognisedtextssuchasIndianPharmacopoeia(IP),AyurvedaPharmacopoeiaofIndia(API),BureauofIndianStandards(BIS),QualityStandardsofIndianMedicinalPlants,BritishPharmacopoeia(BP),USPharmacopoeia(USP),FoodChemicalCodex,JECFAasappropriatetotheingredientorsubstancebeingused.
ThespecificationsadoptedbytheFBOfortheingredientsorsubstancesusedinthemanufactureorsaleofproductsshouldbeincludedinappropriatedocumentationincludingtheiranalyticalmethodologyandconformancereportsandmadeavailableatthetimeofinspectionorwhenrequiredsubmittedtotheFoodAuthority.
TheFBOisrequiredtocomplywiththespecificationsqualityandpurityoftheingredientsbeingusedandtheapplicablesamplingandtestmethodsusedtocharacteriseoridentifytheingredients.ThesemayberequiredatthetimeoflicensingorwheneverrequiredbytheFood Authority.
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E. Food AdditivesFoodadditivesspecifiedforHealthSupplementsandNutraceuticalsmaybeused,provided below.
FoodAdditives Health Supplements Nutraceuticals
Schedule VA
Schedule VE
Schedule VF*
*Foodadditivestobeusedinformatssuchastablets,capsulesand syrups
F.Ingredientsnotincludedin the SchedulesTheFSS(HSN)2016hasenteredintoforceon1stJanuary2018,afterprovidingayearforcompliance.Productsinthemarketarenowrequiredtobefullycompliantwiththe regulation.
TheAuthorityhasgrantedextensionuptosixmonthsforproductstocomplyiftheymeetcertainconditions.FBO’sarefurtheradvisedtoconsulttheAuthoritywithregardamendmentsthatmayfollow.
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G.Non-specifiedfoodsTheFSS(ApprovalforNonSpecifiedfoodandfoodIngredients)Regulation2017hasbeennotified.TheregulationwillreplacetheerstwhileproductapprovalprocedurethatwasinplaceuntilAugust19,2015.
TheregulationrelatestotheproceduretobefollowedbyFBO’sseekingtoobtainapprovalforanovelfoodoringredient,productfromnoveltechnology,newfoodadditive,processingaidsincludingenzymes,articlesoffoodconsistingorisolatedfrommicroorganisms,bacteria,yeast,fungioralgaeoranyothernon-specifiedfood.
TheregulationappliestoallingredientsandsubstancesasstatedaboveincludingthosetobeusedinfoodsupplementsandNutraceuticals.
CompositionofHealthSupplementsandNutraceuticals
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Section 5
LicensingandImport
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Applicableto
Health Supplements Nutraceuticals
1. Licensing:EveryFoodBusinessOperatorinthesupplychainisrequiredtopossessalicence,e.g.manufacturing,import,storage,distribution,sale,marketingortransport,oncommencementofbusiness.
2. Importoffoods,includingHealthSupplementsandNutraceuticalsaresubjecttotheFSS(Import)Regulations2017.NopersonshallimportanyarticleoffoodwithoutanimportlicencefromtheCentralLicensingAuthorityinaccordancewiththeprovisionsoftheFoodSafetyandStandards(LicensingandRegistrationofFoodBusinesses)Regulations2011.
3. TheFBOisadvisedtorefertotheregulationsandamendmentsthereofinforcenamely:
- FSS(LicensingandRegistrationofFoodBusinesses)Regulations2011
- FSS(Import)Regulations2017
Section 6
Glossary and Abbreviations
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ASEAN AssociationofSoutheastAsianNations
FSSA FoodSafetyandStandardsAct,2006
FSS FoodSafetyandStandards
FSS(HSN)2016 FoodSafetyandStandards(HealthSupplements,Nutraceuticals,FoodsforSpecialDietaryUses,FoodsforSpecialMedicalPurposes,FunctionalFoods,NovelFoods)Regulation2016
FSS(PL)2011 FoodSafetyandStandards(PackagingandLabelling)Regulations2011
FSS(FPSFA)2011 FoodSafetyandStandards(FoodProductStandardsandFoodAdditives)Regulations2011
FSS(FPSFA)2011-7A FoodSafetyandStandards(FoodProductStandardsandFoodAdditives)Regulations2011:7thAmendment2016
FSSAI FoodSafetyandStandardsAuthorityofIndia
FSDU Foodsforspecialdietaryuses
FSMP Foodsforspecialmedicalpurpose
FBO Food Business Operator
FoodAuthority FoodSafetyandStandardsAuthorityofIndia
ICMR IndianCouncilofMedicalResearch
LM(PCR)2011 LegalMetrology(PackagedCommodity)Rules2011andamendments thereto.
NRV Nutrientreferencevalue
PDP PrincipalDisplayPanel
RDA Recommendeddietaryallowanceorrecommendeddailyallowance
Copyright © 2018 CII and IADSA Resource Centre for Health Supplements and Nutraceuticals (RecHaN). All rights reserved.
Nopartofthispublicationmaybereproduced,storedin,orintroducedintoaretrievalsystem,ortransmittedinanyformorbyanymeans(electronic,mechanical,photocopying,recordingorotherwise),inpartorfullinanymannerwhatsoever,ortranslatedintoanylanguage,withoutthepriorwrittenpermissionofthecopyrightowner.RecHaNhasmadeeveryefforttoensuretheaccuracyoftheinformationandmaterialpresentedinthisdocument.Nonetheless,allinformation,estimatesandopinionscontainedinthispublicationaresubjecttochangewithoutnotice,anddonotconstituteprofessionaladviceinanymanner.NeitherRecHaNnoranyofitsofficebearersoranalystsoremployeesacceptorassumeanyresponsibilityorliabilityinrespectoftheinformationprovidedherein.
However,anydiscrepancy,error,etc.foundinthispublicationmaypleasebebroughttothenoticeofRecHaNforappropriatecorrection.
Published by ReCHaN (CII and IADSA Resource Centre on Health Supplements and Nutraceuticals)
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